1. Field of the Invention
The present invention relates generally to methods and apparatus for accessing the uterus and optionally the fallopian tubes of a patient. More particularly, the present invention relates to a uterine access catheter system and method which provide for both uterine access and manipulation.
Diseases of the fallopian tubes are a major cause of infertility and tubal pregnancy. Until recently, diagnosis and treatment of tubal disease has been hampered by the difficulty of accessing and imaging the interior of the fallopian tubes in a least invasive manner. Such difficulties, however, have been largely overcome by the present availability of very small guidewires, catheters, and fiberoptic viewing scopes, usually referred to as falloposcopes. Particular systems and methods employing a hysteroscope in combination with the guidewire and small diameter fallopian access catheter for accessing and viewing the interior of the fallopian tubes are described in Kerin et al. (1990) Fertil. Steril. 54:390-400 and J. Laparo. Endoscopic Surg. 1:47-56, and copending patent application Ser. No. 08/207,475, assigned to the assignee of the present application.
A common medical procedure for imaging the uterus and fallopian tubes is referred to as hysterosalpingography. Such procedures rely on injecting contrast media into the uterus and fallopian tubes using a uterine access catheter having an elastomeric balloon near its distal end for sealing against the cervix. The anatomical structures of the uterus and fallopian tubes are then filled with contrast media fluoroscopically imaged in a conventional manner. In some cases, however, contrast media injected into the uterus does not fully pass into the fallopian tubes. If the fallopian tubes are not filled with the contrast media, subsequent imaging may be inadequate.
In such circumstances, it has been proposed to pass a pair of coaxial catheters through the uterine access catheter in order to access the fallopian tubes. In particular, an outer catheter is used to engage the fallopian os and a smaller tubular catheter is passed through the outer catheter and into the fallopian tube. Contrast media can then be injected directly into the fallopian tube for improved imaging. Such systems are described in U.S. Pat. No. 5,372,584.
While such coaxial catheter systems for selectively accessing the uterus and fallopian tubes are generally successful, they rely on using a relatively large diameter uterine access catheter. In particular, the uterine access catheter must be sufficiently large to pass the coaxial catheter system which is used to enter the fallopian tubes. The need to pass a larger catheter through the cervix significantly increases patient discomfort and can be more difficult for the physician to insert. While it would be possible to initially employ a small catheter for contrast media introduction, subsequent fallopian tube access would then require use of a second, larger uterine access catheter, thus increasing the cost and complexity of the procedure.
A further deficiency of presently utilized uterine access systems is the inability to or difficulty of manipulating the uterus during the hysterosalpingography or other imaging procedure. Frequently, it would be desirable to reorient the uterus to improve the fluoroscopic image or for other purposes. While a variety of uterine manipulating devices exist, most are incapable of fluid injection for fluoroscopic imaging. While combination uterine injectors and manipulators do exist, such as those available from BEI Medical Systems, Inc., under the tradenames ZUMI AND ZUI (which are generally described in U.S. Pat. No. 4,430,076), the handle which is attached over the balloon catheter for engaging the interior surface of the cervical os is difficult to properly position over the inner balloon catheter. Moreover, the handle is useful only for manipulation and does not provide uterine access for the introduction of other uterine and/or fallopian catheters. In contrast, the catheter system described in U.S. Pat. No. 5,372,584, is not useful for uterine manipulation. The '584 catheter has a disk which engages the outside of the cervix to maintain a seal. While sufficient to provide the desired seal, if the '584 catheter were used to manipulate the uterus, the seal provided by the disk would be stressed and the seal lost.
For these reasons, it would be desirable to provide improved apparatus and methods for accessing and manipulating the uterus in hysterosalpingography and other procedures. Such apparatus and methods will preferably provide for the introduction of a small diameter balloon catheter having a sleeve catheter thereover, where the assembly of the balloon catheter and sleeve catheter together provides sufficient rigidity and column strength to permit manipulation of the uterus and wherein the balloon catheter may be withdrawn from the sleeve catheter to permit use of the sleeve catheter for other purposes, such as the introduction of uterine and/or fallopian tube catheters. Such apparatus and methods should reduce the complexity and cost of performing hysterosalpingography and other related uterine and fallopian tube access procedures. It would further desirable if such apparatus were useful for other gynecological procedures, such as treatment of proximal tubal occlusion, endoscopic tubal examination, transcervical gamete intrafallopian transfer (GIFT), therapeutic drug delivery for treatment of infections and ectopic pregnancies, endometrial biopsy, intrauterine ultrasound, and the removal of myomas, polyps, and/or septums, and the like.
2. Description of the Background Art
U.S. Pat. No. 5,372,584, describes a catheter system for performing hysterosalpingography and selective salpingography. Catheter systems and methods for accessing the fallopian tubes are described in U.S. Pat. Nos. 5,389,089; 5,379,247; 5,300,023; and 5,147,315. Catheters intended for uterine access and/or manipulation are described in U.S. Pat. Nos. 5,259,836; 5,104,377, 4,496,345; 4,430,076; and WO 96/22122. Other catheter systems are described in U.S. Pat. Nos. 5,273,526 and 5,211,627. A cervical cannula is described in SU 730355. Laparoscopic cannulas comprising coaxial tubular members are described in U.S. Pat. Nos. 5,002,557 or 5,176,697. A cervical manipulator comprising an inner balloon member and other cervical cap is described in U.S. Pat. No. 5,209,754. Devices manufactured under U.S. Pat. No. 4,430,076, are sold by BEI Medical Systems under the trade name ZUMI, as described in a catalogue of BEI.
A coaxial catheter system for accessing and imaging a fallopian tube is described in copending application Ser. No. 08/207,475, filed on Mar. 7, 1994, assigned to the assignee of the present application, the full disclosure of which is incorporated herein by reference.